inVentiv Health Freelance Clinical Research Associate, Germany in Germany
Title Freelance Clinical Research Associate, Germany
Job ID 14475
Position Overview We are looking for an experienced Freelance CRA who can support our German phase II – IV group on various projects. The Freelancer is supposed to cover this project to 0.8 – 1.0FTE on a six months basis.
Responsibilities • Perform either on-site or remote site visits and monitoring activities in accordance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements, and complete appropriate documentation (confirmation, follow-up letters, trip reports and /or communication logs) as required.
• Mentor CRAs on monitoring, internal procedures, and query resolution.
• Use expertise and judgement to identify and resolve complex site issues and deficiencies in documentation, communication, and the need for additional training.
• Assess and ensure overall integrity of study and adherence to guidelines, protocols, and regulations.
• Evaluate overall performance of site and site staff.
• Ensure compliance and understanding of study requirements by site staff.
• Provide recommendations regarding site-specific actions and use judgment and expertise to assess ability of site staff.
• Interpret data to identify protocol deviations or major risks to data integrity.
• Understand project scope, budgets, and timelines and be able to provide input and manage project objectives to meet timelines.
• Act as a liaison between the company and study site personnel and be able to respond to site concerns and questions.
• May interact with representatives of Client affiliates both within and outside clinical.
• Review and verify case report forms and other clinical data for completeness and accuracy.
• Monitor patient safety and identify and address any protocol deviations and make appropriate recommendations.
• Generate queries and manage resolutions with site staff.
• Obtain, review and process regulatory and administrative documents from investigator sites.
• Maintain project tracking systems as required.
• Participate in the identification and selection of investigators and clinical sites.
• Assist in the development of study specific monitoring procedures and guidelines.
• Mentor junior staff on training, guidelines, and processes.
• Complete assigned training programs and apply learning.
• Maintain working knowledge of GCP/ICH Guidelines as well as all applicable regulations.
Ability to travel as necessary may be up to 70% depending on assignments. Overnight and occasional weekend travel may be required
Requirements • Several years clinical research experience with solid prior clinical monitoring experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Strong organizational skills
• Must demonstrate good computer skills.
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
Country Germany [DE]